Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00557258

First received: November 9, 2007

Last updated: February 12, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2007

Last Updated Date

February 12, 2009

Start Date ^ICMJE

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

To assess the prevalence of RLS in patients presenting with unpleasant sensations of the legs

Change History

Complete list of historical versions of study NCT00557258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Common differential diagnoses in patients presenting with leg problems Prevalence of unpleasant sensations of the legs in a patient population consulting a GP on that day Impact of unpleasant leg sensations on the daily life of patients

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Official Title ^ICMJE

Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Brief Summary

The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care practices in Germany. The study will be conducted on a fixed day in November 2007.

Primary care surgeries throughout Germany will be asked to take part. The study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. Physicians who want to take part in the study will send a signed contract to BI. Physicians will be trained to diagnose RLS.

All patients attending the participating surgeries on a fixed day will be invited to participate in the study. The patients will be handed a questionnaire to fill out while waiting for their appointment. No patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. Therefore, no written informed consent will be obtained from the participants.

The patient questionnaire will consist of the following items:

A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file) Additional questions concerning the impact of the patients leg problems on daily life.

The practice staff will then collect the questionnaire. All patients who have answered question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be assessed for the diagnosis by the physician.

The physician fills out a second questionnaire, covering the following items:

Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed questionnaires will be sent to data management by the surgery within 2 working days.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Restless Legs Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

14956

Completion Date

Not Provided

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients attending one of the participating primary care surgeries on a fixed day
Male or female patients of any age

Exclusion Criteria:

Patients who only attend the practice to get a prescription and are not seen by the doctor on that day.
Patients who are not able to understand the questionnaire due to mental impairment or language problems.
Children and adolescents under the age of 18 years

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00557258

Other Study ID Numbers ^ICMJE

248.652

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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